MAUDE Adverse Event Report: ETHICON INC. PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Frequency (2275); Discomfort (2330); Insufficient Information (4580)

Event Date 09/28/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.  the single complaint was reported with multiple events.There are no additional details regarding the additional events.  citations:http://dx.Doi.Org/10.1016/j.Ejogrb.2013.09.045.  no additional information is available.If further details are received at a later date a supplemental medwatch will be sent.Adverse events associated with prolift +m pelvic floor repair device reported via mw # 2210968-2021-05187.Adverse events associated with tension free vaginal tape - obturator device reported via mw # 2210968-2021-05189.Adverse events associated with tension free vaginal tape - secur device reported via mw # 2210968-2021-05190.Adverse events associated with tension free vaginal tape - abbrevo device reported via mw # 2210968-2021-05191.

Event Description

It was reported in a journal article with title: anterior needle-guided mesh in advanced pelvic organ prolapse:apical fixation on sacrospinous ligaments.The objective of this study is to evaluate whether anterior¿apical compartment mesh implants for pelvic floor reconstruction might be safely and effectively anchored to the sacro-spinous (ss) ligaments instead of the arcus tendineus fascia pelvis (atfp).The ss ligaments as anchoring structures for centro-apical support mesh fixation are thought to be stronger than the atfp and we presumed that anterior mesh fixation to the ss ligament might be feasible, safe and effective.This study, started on january 2009 and closed on october 2011, was designed to be open and prospective.Of 72 patients who were asked to participate in this study, 44 had rather un-palpable atfp, and ss ligament fixation was performed.The mean follow-up duration was 12 months.The mesh used here was prolift+ m1 anterior (gynecare, summerville, usa).Apical ss ligament fixation was chosen whenever the atfp was found by an experienced surgeon to be poor to the extent of being difficult to palpate, making it clearly inappropriate for mesh fixation.All patients were given 1 g monocef1 (cefonicid, beecham healthcare) intravenously one hour prior to surgery.They all underwent an iodine antiseptic vaginal wash before the surgery.Patients presenting with additional posterior vaginal wall relaxation had either posterior colporrhaphy or posterior pelvic floor mesh augmentation reconstructive surgery (by prosima1 or prolift + m1, gynecare, somerville, usa), depending on the severity of the herniation process.Mild degrees of prolapse were treated with native tissue colporrhaphy, moderate degrees with single incision small mesh, and advanced prolapse was treated with needle guided large mesh.Anti-incontinence surgery was added when indicated, using tvt obturator, tvt-secur or tvt-abbrevo (gynecare, somerville, usa), according with surgeon¿s preference.Patients were followed up at 1 and 3 months after the surgery and at study conclusion, with the last patient having 10 months of post-operative follow-up as well.Reported complications included urgency (n=12), frequency (n=12) and nocturia (n=12) were all found to be reduced significantly, and so was the sexual discomfort rate(n=6) fecal incontinence (n=1), pelvic pain (n=4) and constipation(n=1) rates were reduced.In conclusion this rather small study suggests that anterior pelvic floor meshes might be anchored safely and successfully to the ss ligament, aiming to achieve improved centro-apical support of the vaginal apex and the anterior wall by an anterior pelvic floor approach.

• Brand Name: PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11925763
• MDR Text Key: 266919215
• Report Number: 2210968-2021-05188
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1